Canadian Cancer Trials Group Bulletins

General


Canadian Cancer Trials Group Clinical Trials Committee approves two new trials

The Canadian Cancer Trials Group Clinical Trials Committee considered ten new trial proposals at the 2008 Spring Meeting of Participants in Toronto. One proposal was referred back to the Disease Site Committee for further development, and the second was given preliminary approval to proceed with negotiation about drug supply and trial development and will subsequently require re-evaluation for full approval. Of the remaining eight proposals, three were approved. Two of these trials would be led by Canadian Cancer Trials Group and one is an Intergroup trial led by CALGB. Since these approvals, one trial has been withdrawn based on negotiations with the potential pharmaceutical collaborator. The two approved trials are:

BR.29 (Canadian Cancer Trials Group-led) -- A Phase II/III Double Blind Randomized Trial of Cediranib versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer. This is a follow-up study to BR.24 This is a randomized, double blind, placebo controlled study testing cediranib (AZD2171) 20 mg per day in combination with paclitaxel/carboplatin in patients with stage IIIB or IV non-small cell lung cancer. The primary outcome is to compare the overall survival between the two arms. Secondary outcomes include progression-free survival, toxicity, QoL, correlative molecular markers looking at markers of angiogenesis, and economic analysis. The projected sample size is 750 patients. This trial is limited to invited centres. Dr. Scott Laurie is the study chair for this trial; Dr. Lesley Seymour is the Physician Coordinator; and Ms. Ann-Marie Bradley is the Study Coordinator.

ALC.2 (CALGB 10603) -- An Intergroup Phase III Randomized Double Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy and PKC412 or Placebo in Newly-Diagnosed Patients <60 with Flt3 Mutated AML. Midostaurin (PKC412) is a potent inhibitor of FLT3 kinase, which is abnormally activated in approximately one-third of patients with newly diagnosed AML. This is a double blind, placebo controlled study testing midostaurin in combination with standard chemotherapy in patients with newly diagnosed AML who have a documented flt-3 mutation. The primary outcome of the study is overall survival. Secondary outcomes include complete response rate, event-free survival, and disease-free survival. The projected sample size is 514 patients. This trial will be open to member centres. Dr. Lois Shepherd is the Physician Coordinator for this trial and Mr. Patrick Smith is the Study Coordinator. A process to name the study chair is underway.